Early Phase 1
Completed N=11
Phendimetrazine and Cocaine
Cocaine Use Disorder
Source: ClinicalTrials.gov NCT02233647 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcomePrimary: Peak Systolic Pressure — 115.4; 121.3; 123.4; 122.1 mm Hg
Summary
This study will determine the safety and tolerability of phendimetrazine (Bontril®) as a pharmacotherapy for cocaine use disorder. A rigorous, inpatient human laboratory study will be conducted in which the subjective and physiological effects of cocaine are evaluated during maintenance on placebo and phendimetrazine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Systolic Pressure |
115.4; 121.3; 123.4; 122.1; 135.4; 120.0 | — |
| PRIMARY Peak Diastolic Pressure |
75.6; 75.2; 78.4; 78; 80.8; 77.2 | — |
| PRIMARY Peak Heart Rate |
75; 72.7; 77.4; 79.2; 87.8; 76.6 | — |
| PRIMARY Peak Temperature |
98.09; 98.12; 98.24; 98.21; 98.04; 98.25 | — |
| SECONDARY Peak Score on Sedative Subscale of the Adjective Rating Scale |
2.3; 2.5; 2.5; 2.4; 4.4; 1.9 | — |
| SECONDARY Peak Score on Stimulant Subscale of the Adjective Rating Scale |
5.2; 5.5; 6.3; 6.6; 8.1; 4.4 | — |
| SECONDARY Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale |
.6; 3.9; 8.9; 7.8; 14; 1.5 | — |
| SECONDARY Peak Ratings of "Any Effect" on the Visual Analog Scale |
1.5; 4.7; 13.2; 16.9; 26; .9 | — |
| SECONDARY Peak Ratings of "Bad Effect" on the Visual Analog Scale |
.6; 2.1; 4.9; 6.6; 8.5; 1.3 | — |
| SECONDARY Peak Ratings of "Euphoric" on the Visual Analog Scale |
1; 1.8; 3.1; 1.2; 1.9; 1 | — |
| SECONDARY Peak Ratings of "Good Effect" on the Visual Analog Scale |
1.2; 7.1; 12.4; 12.3; 19.8; 1.3 | — |
| SECONDARY Peak Ratings of "High" on the Visual Analog Scale |
1.4; 6; 14.1; 11.9; 23.4; 1.1 | — |
| SECONDARY Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale |
.8; 2.8; 10.8; 9.2; 14.6; .4 | — |
| SECONDARY Peak Ratings of "Like Drug" on the Visual Analog Scale |
1; 6.4; 12.9; 14; 23.2; .5 | — |
| SECONDARY Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale |
1.4; 3.3; 3.1; 7.8; 14; .6 | — |
| SECONDARY Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale |
.7; 2.3; 3.7; 4.1; 9.4; .6 | — |
| SECONDARY Peak Ratings of "Willing to Pay For" on the Visual Analog Scale |
.9; 4.4; 8.2; 11.2; 20.2; 1.1 | — |
| SECONDARY Peak Ratings of "Performance Impaired" on the Visual Analog Scale |
.8; .7; 1.9; 3.3; 3.4; 1 | — |
| SECONDARY Peak Ratings of "Performance Improved" on the Visual Analog Scale |
.7; .7; 1.4; 1.4; 6.6; .7 | — |
| SECONDARY Peak Ratings of "Restless" on the Visual Analog Scale |
.5; 1.9; .7; 1.8; 2.3; .5 | — |
| SECONDARY Peak Ratings of "Rush" on the Visual Analog Scale |
.5; 4.4; 11.9; 11.4; 17.4; .9 | — |
| SECONDARY Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale |
1.7; 1.8; 6.1; 6; 11.9; .4 | — |
| SECONDARY Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale |
1.7; 1.8; 1.09; 3.3; 8.5; .6 | — |
| SECONDARY Peak Ratings of "Stimulated" on the Visual Analog Scale |
1.8; 2; 5.6; 5.1; 10.8; .8 | — |
| SECONDARY Peak Ratings of "Willing to Take Again" on the Visual Analog Scale |
1.1; 9.8; 14.1; 16.5; 22.9; 1.5 | — |
| SECONDARY Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale |
1; 2.7; 3.9; 3.5; 4.3; .6 | — |
Eligibility Criteria
Inclusion Criteria
- Recent cocaine use
Exclusion Criteria
- Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
- Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
- History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
- Females not currently using effective birth control
- Contraindications to cocaine or phendimetrazine
Data sourced from ClinicalTrials.gov (NCT02233647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.